# K072917: JJG Evolution Orthodontic Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Odontit S.A.
- Decided: Jan 14, 2008 after 94 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894595 (1990). 135 ancestors in all.
No later device cites it as a predicate yet.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980620: Dentatus Mti  Modular Transitional Implants and Prosthetic System, Dentatus USA, Ltd. (1998) Summary page 1.
- K961704: Mti-MP Transitional Implants and Modular Prosthetic System, Dentatus USA, Ltd. (1996) Summary page 1.
- K972351: Sendax Mdi (Mini Dental Implant), Sendax Mdic Management, Inc. (1997) Summary page 1.
- K983120: Bicortical Screw, Oraltronics Marketing-Und Vertriebs GmbH (1999) Summary page 1.
- K960417: 3I STND Threaded/Self Tapping Threaded/3I Miniplant Implants/3 I Emergence Prof. Temp. Healing Abutments, Implant Innovations, Inc. (1996) Summary page 2.
- K063770: Alpha-Bio Orthodontic Fixation Screw System, Alpha-Bio Tec, Ltd. (2007) Summary page 3.
- K062733: Tomas Pin SD 6, 8, and 10 MM, Dentaurum (2006) Summary page 3.
- K062367: Miniscrews Anchoring System, M.a.S., Micerium S.P.A. (2006) Summary page 3.
- K062156: Super Orthodontic Screw, Osstem Implant Co., Ltd. (2006) Summary page 3.
- K060062: Straumann Orthosystem, Institut Straumann AG (2006) Summary page 3.
- K050568: Orlus Mini Screw, Ortholution Co., Ltd. (2005) Summary page 3.
- K042965: Tomas Pin, Dentaurum, Inc. (2005) Summary page 3.
- K031936: Osteomed Orthodontic Screw System, Osteomed LP (2004) Summary page 4.
- K071235: Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13, Zimmer Dental, Inc. (2007) Summary page 7.
- K070905: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 7.
- K070022: Mistral - One Stage Screw-Type Dental Implant, Model MF9, Mis Implants Technologies, Ltd. (2007) Summary page 7.
- K062281: Zimmer One-Piece Implant, 4.7MM, Straight, Models ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16, Zimmer Dental, Inc. (2006) Summary page 7.
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System, Astra Tech, Inc. (2006) Summary page 7.
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 7.
- K023952: Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite, Nobel Biocare Uas, Inc. (2003) Summary page 7.
- K961631: Odont Hex System, Odontit S.A. (1997) Summary page 7.
- K915375: Odontit Osseointegrated Implants System, Odontit Systeme (1992) Summary page 7.
- K011502: Crystal and Crystal-Care Implants System, Crystal-Seal Dental Implants (2001) Summary page 7.

## Indications for use
These devices are intended for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge installations for full or partial edlentualism such as: Support anchors for temporary restorations during the healing and osseointegration process of permanent implants, Immediate loading temporary abutments for repairing failing tooth and implant supported restorations, Transitional supports for immediate replacement of missing teeth, For use in front maxilla where 4 or more implants are splinted together, may be loaded immediately. This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It may be used for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K072917
Methodology: https://510kreport.com/methodology